InflammationNCT05385055

Reduction of Exposure, Inflammation, and Oxidative Stress Following at Least 2 Years of Switching to THS Use Compared to Cigarette Smoking

An observational study of Inflammation and Oxidative Stress, run by Philip Morris Products S.A. at 37 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a cross-sectional 3-group study with subjects enrolled and matched by region (Asia, Europe), age, sex, and average daily product consumption over the last 2 years as self-reported. The study will be conducted as a multi-center and multi-regional study. Read more about this study

Who is it for?: Ages 30 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Inflammation, Oxidative Stress, Smoking
What is being tested?: THS use, Cigarette smoking and Smoking abstinence
How many people: 974 participants
Where: 37 sitesin 6 countries
Study dates: 13 Jun 2022to 23 Apr 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 60 years
All sexes
Healthy volunteers accepted
Adult

Study population: The study population was recruited through social media and traditional display advertising. The subjects included current cigarette smokers, current THS users (with a minimum of 2 years THS use), and former cigarette smokers (with a minimum of 2 years of smoking abstinence).

Who may be able to join

Subject is able to understand the information provided in the main ICF and has signed the main ICF.
Subject is 30-60 years old.
Subject is healthy based on ECG, spirometry, vital signs, physical examination, medical history and Investigator's assessment.
Cigarette smokers:
Has smoked ≥ 10 cigarettes/day on average (no brand restriction) over the past 2 years prior to screening.
Has smoked ≥ 10 cigarettes/day on average (no brand restriction) for at least 10 years.

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Has not used other tobacco and nicotine products apart from cigarettes on a daily basis over the past 2 years prior to screening.
Smoking status will be verified by urinary cotinine test (≥ 200 ng/mL) and CO breath test (≥ 10 ppm (1)).
THS users:
Has used ≥ 10 HeatSticks/day on average over the past 2 years prior to screening.
Has smoked ≥ 10 cigarettes/day on average (no brand restriction) for at least 8 years prior to switching to THS.
Has smoked < 30 cigarettes/month and used other tobacco products or e-cigarettes < daily over the past 2 years prior to screening.
Product use will be verified by urinary cotinine test (≥ 200 ng/mL) and CO breath test (< 10 ppm).
Former cigarette smokers:
Has not smoked cigarettes or used any tobacco or nicotine-containing products on a daily basis over the past 2 years prior to screening.
Has smoked ≥ 10 cigarettes/day on average (no brand restriction) for at least 8 years prior to stopping smoking.
Smoking status will be verified by urinary cotinine test (< 100 ng/mL) and CO breath test (< 10 ppm).

Who cannot join

As per the judgment of the Investigator, the subject cannot participate in the study for any reason (e.g., medical, psychiatric and/or social reason). The Investigator should specifically evaluate the subject's eligibility considering COVID-19 risk factors and local situation.
The subject is legally incompetent or physically/mentally incapable of giving consent (e.g., emergency situation, under guardianship, in a social or sanitary establishment, prisoner or involuntarily incarcerated).
The subject has/had clinically relevant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, urological, immunological, pulmonary, and cardiovascular disease) or conditions that in the opinion of the investigator would jeopardize the safety of the subject or affect the validity of the study results.
The subject has abnormal findings on physical examination, ECG, vital signs, spirometry or in the medical history, deemed clinically significant by investigators.
The subject has/had within 30 days prior to screening a body temperature >37.5°C or an acute illness (e.g., upper-respiratory-tract infection, viral infection, etc.…) or the subject is confirmed or suspected active COVID-19 infection (based on the signs and symptoms observed at the time of assessment) at screening.
The subject has used any prescribed or over-the-counter systemic medication with an impact on WBC or 8-epi-PGF2α within 5 half-lives of the medication prior to enrollment in the study (please refer to Appendix B).

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Subject has high blood pressure (hypertension), defined as > 139 mmHg systolic and/or > 89 mmHg diastolic or is currently treated with medication controlling high blood pressure.
The subject has (FEV1/FVC) < 0.7 and FEV1 < 80% predicted value at post-bronchodilator (BD) spirometry.
The subject has (FEV1/FVC) < 0.75 (pre-BD) and reversibility in FEV1 (that is both > 12% and > 200 mL from pre- to post-BD values).
The subject has a history of allergic reactions to salbutamol.
The subject has a body mass index (BMI) < 18.5 or ≥ 30 kg/m2.
The subject has positive alcohol and/or drug screening test results.
The subject has donated or received whole blood or blood products within 3 months prior to V1.
The subject has been previously screened for this study.
The subject is a current or former employee of the tobacco or e-cigarettes industry or of their first-degree relatives (parent, sibling, and child).
The subject is an employee of the investigational site or any other parties involved in the study or of their first-degree relatives (parent, sibling, and child).
The subject has participated in a clinical study within 3 months prior to V1.
For women only: the subject is pregnant (does have a positive pregnancy test) or breast-feeding.

Trial locations and contacts

37 sites in 6 countries.

Country

City, postcode or hospital

37 sites in 6 countries

Germany11 sites

Velocity Clinical Research Germany GmbH
Berlin, 10787
emovis GmbH
Berlin
Synexus Clinical Research GmbH
Frankfurt, 60313
Klinische Forschung Hamburg GmbH
Hamburg, 20253
Klinische Forschung Hannover-Mitte GmbH
Hanover, 30159
Klinische Forschung Karlsruhe GmbH
Karlsruhe, 76137
Velocity Clinical Research Leipzig
Leipzig, 4103
Centrum für Diagnostik und Gesundheit, Klinische Forschung und Entwicklung
München
Schaum/Hecht_RED Institut fur medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, 23758
Praxis Reinfeld Mitte
Reinfeld
Klinische Forschung Dresden GmbH
Sachsen, 1069

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Japan8 sites

Hakata Clinic
Fukuoka
Yokohama Minoru Clinic
Kanagawa, 2320064
Nishikumamoto Hospital
Minami
OPHAC Hospital
Osaka, 5320003
OCROM Clinic
Osaka, 6560853
ToCROM Clinic
Tokyo, 160-0008
Samoncho Clinic
Tokyo, 1600017
Sumida Hospital
Tokyo

Other trials in Japan

Czechia7 sites

Private Internal ambulance
Karlovy Vary, 360 17
PreventaMed s.r.o.
Olomouc, 77900
Praglandia s.r.o.
Prague, 15000
Clintrial s.r.o.
Prague
Ordinance praktickeho lekai'e
Přeštice, 33401
Zdravi - fit, s.r.o.
Protivín, 398 11
Vestra Clinics s.r.o.
Rychnov nad Kněžnou

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Poland5 sites

Centrum Medyczne Pratia
Katowice, 40-081
Clinical Medical Research Sp. z o.o.
Katowice, 40-156
Tomed Tomasz Miszalski-Jamka
Krakow, 31-353
Synexus Polska Sp zoo OddziaL w Lodzi
Lodz, 90-127
Bioresearch Group
Nadarzyn, 05-830

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Bulgaria4 sites

Medical Centre Asklepii
Kyustendil, 2600
Medical Centre Leo Clinic EOOD
Lovech, 5500
Medical Center ReSpiro
Razgrad, 7200
Medical Center Zara-Med EOOD
Stara Zagora, 6000

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Greece2 sites

National and Kapodistrian University of Athens, Medical school, Attikon Hospital, 2nd Cardiology Department
Athens
Aristotle University Thessaloniki/Papageorgiou Hospital
Thessaloniki, 56403

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About this study

Official title: A Cross-sectional, Multi-regional Study to Demonstrate Reduction in Exposure to Key Toxicants, Oxidative Stress, and Inflammation Following at Least 2 Years of Tobacco Heating System (THS) Use Compared to Cigarette Smoking

Read the detailed description

The primary purpose of this study was to demonstrate the beneficial effects of switching from cigarette smoking to THS use for at least two years, compared to continued cigarette smoking, in real-life conditions. This was assessed by examining both inflammation and oxidative stress status as proxies for long-term harm in healthy subjects, using well-established and fit-for-purpose measures of WBC and 8-epi-PGF2α, respectively, as indicators of these pathways.

Additionally, the study anticipated observing differences in lipid metabolism (HDL-C), endothelial dysfunction (sICAM-1), platelet activation (11-DTX-B2), arterial stiffness (AIx), and lung function (FEV1 %pred post-BD).

The study also aimed to demonstrate additional benefits on other mechanistic pathways related to inflammation and oxidative stress through the use of additional biomarkers of potential harm (BoPH). Furthermore, it sought to assess the association with functional benefits that are expected to respond to the extent of exposure to harmful and potentially harmful constituents (HPHCs).

Conditions: Inflammation, Oxidative Stress, Smoking, Smoking Abstinence
Being tested: THS use, Cigarette smoking, Smoking abstinence
Medical subject headings: Inflammation, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

THS useOther
N/A: No intervention was assigned.
Cigarette smokingOther
N/A: No intervention was assigned.
Smoking abstinenceOther
N/A: No intervention was assigned.

Study groups in NCT05385055
Study group	Role	What they receive
Cigarette		Current cigarette smokers Receives: Other: Cigarette smoking
THS		THS users with a minimum of 2 years of THS use Receives: Other: THS use
SA		Former cigarette smokers with minimum of 2 years of smoking abstinence Receives: Other: Smoking abstinence

What is being measured

The primary outcome is the main question the study is designed to answer.

Carboxyhemoglobin (COHb) in Blood
Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as percentage of the total hemoglobin saturated with carbon monoxide.
Measured: Measured when subject visits study site on day 1.
Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) in Urine
Concentrations of total NNAL measured in urine and expressed as concentration adjusted for creatinine (pg/mg creatinine).
Measured: Measured when subject visits study site on day 1.
White Blood Cell Total Count (WBC) in Blood
Total count in blood (10^9 cells/ L). Mean values are provided.
Measured: Measured when subject visits study site on day 1.
8-epi-Prostaglandin-F2α (8-epi-PGF2α) in Urine
Concentrations of 8-epi-PGF2α measured in urine and expressed as concentration adjusted for creatinine (pg/mg creatinine).
Measured: Measured when subject visits study site on day 1.

Secondary outcomes (5)

High-Density Lipoprotein Cholesterol (HDL-C)
Concentrations of HDL-C (mmol/L) measured in serum.
Measured: Measured when subject visits study site on day 1.
Soluble Intercellular Adhesion Molecule-1 (sICAM-1)
Concentrations of sICAM-1 (ng/mL) measured in plasma.
Measured: Measured when subject visits study site on day 1.
11-dehydrothromboxane B2 (11-DTX-B2)
Concentrations of 11-DTX-B2 measured in urine and expressed as concentration adjusted for creatinine (pg/mg creatinine).
Measured: Measured when subject visits study site on day 1.
Augmentation Index (AIx)
The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure.
Lower AIx values indicate healthier, more flexible arteries and better cardiovascular outcomes, while higher AIx values reflect greater arterial stiffness and worse outcomes.
AIx assessments were conducted using a SphygmoCor XCEL device or similar according to the manufacturer's instructions.
Measured: Measured when subject visits study site on day 1.
Forced Expiratory Volume in 1 Second (FEV1) %Predicted, Post-bronchodilator (Post-BD)
FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred).
Measured: Measured when subject visits study site on day 1.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 202223 Apr 2024

First posted23 May 2022
Study start13 Jun 2022
Primary completion27 Dec 2023
Study completion23 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InflammationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 974 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05385055
Sponsor's protocol ID: P1-RMC-03-INT
Status last verified: May 2026
First submitted: 17 May 2022
Last updated: 8 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ansari SM, Leroy P, de La Bourdonnaye G, Pouly S, Reese L, Haziza C. Differences in biomarkers of potential harm after 2+ years of tobacco heating system use compared to cigarette smoking: a cross-sectional study. Biomarkers. 2025 Mar;30(2):178-191. doi: 10.1080/1354750X.2025.2461069. Epub 2025 Feb 19.
PubMed 39882959

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Cross-sectional, Multi-regional Study to Demonstrate Reduction in Exposure to Key Toxicants, Oxidative Stress, and Inflammation Following at Least 2 Years of Tobacco Heating System (THS) Use Compared to Cigarette Smoking
ClinicalTrials.gov ID: NCT05385055
Acronym / sponsor ID: P1-RMC-03-INT
Conditions: Inflammation, Oxidative Stress, Smoking, Smoking Abstinence
Study type: Observational
Recruitment status: Completed
Enrolment: 974 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: 13 Jun 2022 (actual)
Primary completion: 27 Dec 2023 (actual)
Study completion: 23 Apr 2024 (actual)
First posted: 23 May 2022 (actual)
Results: Posted 8 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 3

Arm	Type	Receives
Cigarette	–	Other: Cigarette smokingCurrent cigarette smokers
THS	–	Other: THS useTHS users with a minimum of 2 years of THS use
SA	–	Other: Smoking abstinenceFormer cigarette smokers with minimum of 2 years of smoking abstinence

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: The study population was recruited through social media and traditional display advertising. The subjects included current cigarette smokers, current THS users (with a minimum of 2 years THS use), and former cigarette smokers (with a minimum of 2 years of smoking abstinence).

Key inclusion criteria (17 listed)

Subject is able to understand the information provided in the main ICF and has signed the main ICF.
Subject is 30-60 years old.
Subject is healthy based on ECG, spirometry, vital signs, physical examination, medical history and Investigator's assessment.
Has smoked ≥ 10 cigarettes/day on average (no brand restriction) over the past 2 years prior to screening.
Has smoked ≥ 10 cigarettes/day on average (no brand restriction) for at least 10 years.

Key exclusion criteria (18 listed)

As per the judgment of the Investigator, the subject cannot participate in the study for any reason (e.g., medical, psychiatric and/or social reason). The Investigator should specifically evaluate the subject's eligibility considering COVID-19 risk factors and local situation.
The subject is legally incompetent or physically/mentally incapable of giving consent (e.g., emergency situation, under guardianship, in a social or sanitary establishment, prisoner or involuntarily incarcerated).
The subject has/had clinically relevant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, urological, immunological, pulmonary, and cardiovascular disease) or conditions that in the opinion of the investigator would jeopardize the safety of the subject or affect the validity of the study results.
The subject has abnormal findings on physical examination, ECG, vital signs, spirometry or in the medical history, deemed clinically significant by investigators.
The subject has/had within 30 days prior to screening a body temperature >37.5°C or an acute illness (e.g., upper-respiratory-tract infection, viral infection, etc.…) or the subject is confirmed or suspected active COVID-19 infection (based on the signs and symptoms observed at the time of assessment) at screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
THS useN/A: No intervention was assigned.	Other	THS
Cigarette smokingN/A: No intervention was assigned.	Other	Cigarette
Smoking abstinenceN/A: No intervention was assigned.	Other	SA

Primary outcome

Carboxyhemoglobin (COHb) in Blood
Time frame: Measured when subject visits study site on day 1.
Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as percentage of the total hemoglobin saturated with carbon monoxide.
Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) in Urine
Time frame: Measured when subject visits study site on day 1.
Concentrations of total NNAL measured in urine and expressed as concentration adjusted for creatinine (pg/mg creatinine).
White Blood Cell Total Count (WBC) in Blood
Time frame: Measured when subject visits study site on day 1.
Total count in blood (10^9 cells/ L). Mean values are provided.
8-epi-Prostaglandin-F2α (8-epi-PGF2α) in Urine
Time frame: Measured when subject visits study site on day 1.
Concentrations of 8-epi-PGF2α measured in urine and expressed as concentration adjusted for creatinine (pg/mg creatinine).

5 secondary outcomes

High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Measured when subject visits study site on day 1.
Soluble Intercellular Adhesion Molecule-1 (sICAM-1)
Time frame: Measured when subject visits study site on day 1.
11-dehydrothromboxane B2 (11-DTX-B2)
Time frame: Measured when subject visits study site on day 1.
Augmentation Index (AIx)
Time frame: Measured when subject visits study site on day 1.
Forced Expiratory Volume in 1 Second (FEV1) %Predicted, Post-bronchodilator (Post-BD)
Time frame: Measured when subject visits study site on day 1.

Results and safety

Results posted to the registry on 8 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cigarette	322	322
THS User	329	329
Former Smoker	323	323

Primary outcome: Carboxyhemoglobin (COHb) in Blood

Time frame: Measured when subject visits study site on day 1.. Geometric least squares mean (95% Confidence Interval). Unit: % of CO saturated hemoglobin

Measure	Cigarette n = 295	THS User n = 295	Former Smoker n = 294
Value	3.07 (2.92 to 3.23)	1.52 (1.44 to 1.60)	1.49 (1.41 to 1.57)

Cigarette vs THS User: Geometric Least Square Mean Ratio: 0.495 (95% CI 0.466 to 0.526), p <0.001, t-test, 1 sided
Cigarette vs Former Smoker: Geometric Least Square Mean Ratio: 0.484 (95% CI 0.457 to 0.513), p <0.001, t-test, 1 sided

Population analysed: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Primary outcome: Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) in Urine

Time frame: Measured when subject visits study site on day 1.. Geometric least squares mean (95% Confidence Interval). Unit: pg NNAL/mg creatinine

Measure	Cigarette n = 294	THS User n = 296	Former Smoker n = 296
Value	107.671 (89.004 to 130.253)	20.374 (16.784 to 24.732)	4.456 (3.680 to 5.396)

Cigarette vs THS User: Geometric Least Square Mean Ratio: 0.189 (95% CI 0.160 to 0.224), p <0.001, t-test, 1 sided
Cigarette vs Former Smoker: Geometric Least Square Mean Ratio: 0.041 (95% CI 0.035 to 0.048), p <0.001, t-test, 1 sided

Primary outcome: White Blood Cell Total Count (WBC) in Blood

Time frame: Measured when subject visits study site on day 1.. Least squares mean (95% Confidence Interval). Unit: 10^9 cells/ L

Measure	Cigarette n = 283	THS User n = 285	Former Smoker n = 287
Value	7.053 (6.800 to 7.305)	6.358 (6.101 to 6.616)	5.893 (5.639 to 6.147)

Cigarette vs THS User: Least Square Mean Difference: -0.694 (95% CI -0.968 to -0.420), p <0.001, t-test, 1 sided
Cigarette vs Former Smoker: Least Square Mean Difference: -1.160 (95% CI -1.420 to -0.900), p <0.001, t-test, 1 sided

Primary outcome: 8-epi-Prostaglandin-F2α (8-epi-PGF2α) in Urine

Time frame: Measured when subject visits study site on day 1.. Geometric least squares mean (95% Confidence Interval). Unit: pg/mg creatinine

Measure	Cigarette n = 294	THS User n = 296	Former Smoker n = 296
Value	224.428 (207.702 to 242.500)	171.469 (158.571 to 185.416)	154.260 (142.718 to 166.735)

Cigarette vs THS User: Geometric Least Square Mean Ratio: 0.764 (95% CI 0.696 to 0.839), p <0.001, t-test, 1 sided
Cigarette vs Former Smoker: Geometric Least Square Mean Ratio: 0.687 (95% CI 0.628 to 0.752), p <0.001, t-test, 1 sided

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a total study duration of up to 2 days for each subject (including a 1-day visit at site followed by a 1-day follow-up period).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cigarette	0 of 322 (0%)	0 of 322 (0%)	0 of 322
THS User	0 of 329 (0%)	0 of 329 (0%)	0 of 329
Former Smoker	0 of 323 (0%)	0 of 323 (0%)	0 of 323

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39882959Ansari SM, Leroy P, de La Bourdonnaye G, Pouly S, Reese L, Haziza C. Differences in biomarkers of potential harm after 2+ years of tobacco heating system use compared to cigarette smoking: a cross-sectional study. Biomarkers. 2025 Mar;30(2):178-191. doi: 10.1080/1354750X.2025.2461069. Epub 2025 Feb 19.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christelle Haziza, PhD study chair

Philip Morris Products S.A.

37 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammation and Oxidative Stress, run by Philip Morris Products S.A. at 37 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Germany, Japan, Czechia, Poland, Bulgaria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Carboxyhemoglobin (COHb) in Blood (time frame: Measured when subject visits study site on day 1.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05385055, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.